teprotumumab-trbw (Tepezza)
teprotumumab-trbw is an FDA-licensed reference biologic from Horizon Therapeutics Ireland DAC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Tepezza teprotumumab-trbw
Horizon Therapeutics Ireland DAC
- Approved
- Jan 21, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for teprotumumab-trbw, in chronological order.
Reference approval
Approval date of the reference teprotumumab-trbw product.
6 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 8 mo
Frequently asked questions
Are there biosimilars approved for teprotumumab-trbw (Tepezza)?
No 351(k) biosimilars or interchangeable biosimilars referencing teprotumumab-trbw are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.